14
Operating Instructions
(Continued)
“Cannot Treat Call Biomet 1.973.299.9300”
This message, accompanied by three audible
beeps, appears when there is a hardware
problem within the controller. The message
“CANNOT TREAT” will appear and alternate
with “CALL BIOMET 1-973-299-9300”. If
the patient needs assistance, they should
call 1.973.299.9300 and ask to speak to a
Patient Support Representative. Outside the
United States contact your local EBI/Biomet
Distributor.
“System Endpoint Call Biomet”,
When the controller’s internal timer reaches
400 days of operation from the first one hour
treatment or 270 therapeutic treatments, the
treatment signal is locked off. The controller’s
LCD display will read “SYSTEM ENDPOINT
CALL BIOMET” This message will appear
every time the controller is turned on. At this
point, the system should be discarded. It is
recommended that the patient contact the
prescribing physician indicating that they have
reached this point in their treatment. See page
22 for Disposal Instructions.
CANNOT TREAT
CALL BIOMET
1-973-299-9300
Alternates with
SYSTEM ENDPOINT
CALL BIOMET
Compliance Data Software Introduction
(Physician Use Only)
This bone healing system contains embedded
software and firmware which allows the display
of patient-specific history data including usage
and therapeutic treatment time via use of
Biomet Compliance Data Download Software.
The Compliance Data Download Software is
classified as a medical device data system
(MDDS). Its primary function is the electronic
retrieval, transfer, display, and storage of
device generated-specific patient history data,
without altering the function or parameters of
the connected device. This software is only
intended to be used and interface with the
following Biomet devices:
• Biomet
®
EBI Bone Healing System
• Biomet
®
SpinalPak
®
Non-invasive Spine
Fusion Stimulator System
• Biomet
®
OrthoPak
®
Non-invasive Bone
Growth Stimulator System
The software is available as a downloadable
executable file to Biomet representatives only
through a secure web portal.
Patient Usage Reports (Physician Use Only)
The Compliance Data Download Software will
download and transfer device-specific patient
history data via a USB cable from the attached
device to a personal computer (PC) and display
it on the PC’s monitor. It can then generate a
read-only report, in Adobe PDF format, which
can be saved or printed. The device does
not record a patient name or diagnosis. The
analysis of the downloaded patient history data
must be limited to the prescribing physician.
The print out/display includes, among other
Summary of Contents for EBI Bone Healing System
Page 1: ...The Biomet EBI Bone Healing System Physician Manual and Package Insert English Language ...
Page 33: ...31 Notes ...
Page 34: ...32 Notes ...
Page 35: ...33 ...
